Difluprednate
- Product NDC
- 0832-6054
- 11-digit product format
- 008326054
- Labeler code
- 0832
- Product ID
- 0832-6054_4af796ab-94c3-c22a-e063-6294a90abcb3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Difluprednate
- Dosage form
- EMULSION
- Route
- OPHTHALMIC
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- ANDA218191
- Marketing category
- ANDA
- Marketing start
- 2025-02-21
- Substance
- DIFLUPREDNATE
- Active strength
- .5 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Difluprednate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIFLUPREDNATE | .5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | S8A06QG2QE |
| Rxcui | 804544 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0832-6054-05 | Difluprednate | 5 mL in 1 BOTTLE | EMULSION | 5 | | 7 |
| 0832-6054-05 | Difluprednate | 1 in 1 CARTON | EMULSION | 1 | | 7 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0832-6054-05 | 00832605405 | 1 BOTTLE in 1 CARTON (0832-6054-05) / 5 mL in 1 BOTTLE | 1 bottle | 2025-08-21 | No | No | Current |